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Comparison of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain After Sleeve Gastrectomy (PGB-ESP)

4 września 2026 zaktualizowane przez: Ergun Gunduz, Atlas University

A Prospective Randomized Controlled Trial Comparing the Effects of Paragastric Nerve Block and Erector Spinae Plane Block on Postoperative Pain Management Following Laparoscopic Sleeve Gastrectomy

Background: Laparoscopic sleeve gastrectomy is one of the most commonly performed bariatric procedures for the treatment of obesity. Despite its minimally invasive nature, patients frequently experience moderate to severe postoperative pain, which may delay mobilization, prolong hospital stay, increase opioid consumption, and reduce patient satisfaction. Effective postoperative pain management is therefore an important component of perioperative care.

Regional analgesia techniques are increasingly used as part of multimodal analgesia protocols to reduce opioid requirements and opioid-related adverse effects. Paragastric nerve block (PGNB) has been reported to provide effective control of visceral pain, nausea, and vomiting after sleeve gastrectomy. Erector spinae plane block (ESPB) is another regional anesthesia technique that has demonstrated efficacy in reducing perioperative opioid consumption in bariatric surgery patients. However, no prospective randomized study has directly compared PGNB and ESPB in patients undergoing sleeve gastrectomy.

This prospective, randomized, controlled clinical trial aims to compare the effects of PGNB, ESPB, and standard analgesia on postoperative pain management following laparoscopic sleeve gastrectomy. Seventy-two adult patients scheduled for elective sleeve gastrectomy will be randomized in a 1:1:1 ratio to receive PGNB, ESPB, or standard multimodal analgesia alone. The primary outcome will be postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, intraoperative remifentanil consumption, additional analgesic requirements, time to first analgesic request, postoperative nausea and vomiting, and block-related complications.

Przegląd badań

Szczegółowy opis

Laparoscopic sleeve gastrectomy is one of the most frequently performed bariatric surgical procedures for the treatment of morbid obesity. Although the procedure is minimally invasive, patients commonly experience moderate to severe postoperative pain during the early postoperative period. Inadequate pain control may delay mobilization, prolong hospital stay, increase pulmonary complications, reduce patient satisfaction, and increase opioid consumption, leading to opioid-related adverse effects such as nausea, vomiting, sedation, and respiratory depression.

Regional anesthesia techniques have become an important component of multimodal analgesia protocols aimed at improving postoperative pain control while reducing opioid requirements. Paragastric nerve block (PGNB) is a surgeon-performed regional analgesic technique targeting visceral afferent nerve fibers surrounding the stomach. Previous studies have suggested that PGNB may reduce postoperative pain, opioid consumption, nausea, and vomiting following sleeve gastrectomy. Erector spinae plane block (ESPB) is an ultrasound-guided fascial plane block that has gained popularity in thoracoabdominal surgery because of its ease of application, favorable safety profile, and potential analgesic benefits. ESPB has been shown to reduce perioperative opioid consumption and improve postoperative analgesia in bariatric surgical patients.

Despite the growing use of both techniques, there is limited evidence directly comparing PGNB and ESPB in patients undergoing laparoscopic sleeve gastrectomy. Therefore, the optimal regional analgesic technique for this patient population remains uncertain.

The present study is designed as a prospective, randomized, controlled, parallel-group clinical trial conducted at Atlas University Faculty of Medicine Hospital. Following Institutional Review Board approval and written informed consent, 72 adult patients scheduled for elective laparoscopic sleeve gastrectomy will be enrolled. Eligible participants will be between 18 and 65 years of age, classified as ASA physical status II-III, and meet established bariatric surgery criteria.

Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups:

  1. Paragastric Nerve Block (PGNB) Group: Patients will receive intraoperative paragastric nerve block performed by the operating surgeon using 18 mL of 0.5% bupivacaine distributed across predefined paragastric anatomical regions.
  2. Erector Spinae Plane Block (ESPB) Group: Patients will receive bilateral ultrasound-guided ESPB at the T6 vertebral level before surgery using 0.25% bupivacaine, with a maximum dose not exceeding 2 mg/kg.
  3. Control Group: Patients will receive standard perioperative multimodal analgesia without regional block intervention.

All participants will undergo standardized general anesthesia and multimodal analgesia protocols. Intraoperative remifentanil administration will be titrated according to routine clinical practice.

The primary outcome measure will be postoperative pain intensity assessed using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery.

Secondary outcome measures will include:

  • Total postoperative analgesic and opioid consumption during the first 24 hours.
  • Additional analgesic requirements.
  • Time to first analgesic request.
  • Intraoperative remifentanil consumption.
  • Incidence of postoperative nausea and vomiting.
  • Block-related adverse events and complications, including local anesthetic systemic toxicity, hematoma, or infection.

Postoperative assessments will be performed by investigators blinded to group allocation whenever feasible. Data will be collected during the intraoperative period, post-anesthesia care unit stay, and throughout the first 24 postoperative hours.

The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of PGNB and ESPB for postoperative pain management following laparoscopic sleeve gastrectomy and may contribute to the optimization of perioperative analgesic strategies in bariatric surgery.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

72

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria: - Age between 18 and 65 years Scheduled for elective Sleeve Gastrectomy surgery Classified as ASA physical status II-III Body mass index (BMI) ≥30 kg/m² with obesity-related comorbidities or BMI ≥40 kg/m² Willing to participate in the study and has provided written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to local anesthetic agents Allergy or contraindication to paracetamol or NSAIDs Coagulopathy or current anticoagulant therapy Infection or skin lesions at the site of block application Chronic pain syndrome Chronic opioid use, opioid dependence, or use of gabapentin/pregabalin Previous upper gastrointestinal surgery Moderate to severe renal impairment (eGFR <60 mL/min/1.73 m²) Moderate to severe liver disease (Child-Pugh B-C or active hepatic disease) Planned additional surgical procedures Inability to assess pain using VAS Refusal to participate in the study

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Paragastric Nerve Block (PGNB)
Participants will receive an intraoperative paragastric nerve block performed by the surgeon using 18 mL of 0.5% bupivacaine administered to predefined paragastric anatomical regions in addition to standard general anesthesia and multimodal analgesia.
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine. The total dose will not exceed 2 mg/kg. The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques. Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
Eksperymentalny: Erector Spinae Plane Block (ESPB)
Participants will receive bilateral ultrasound-guided erector spinae plane block at the T6 vertebral level before surgery in addition to standard general anesthesia and multimodal analgesia.
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine. The total dose will not exceed 2 mg/kg. The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques. Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.
Aktywny komparator: No Intervention
Participants will receive standard perioperative multimodal analgesia without regional anesthesia. Intravenous paracetamol and dexketoprofen will be administered according to the institutional analgesia protocol.
Ultrasound-guided paragastric nerve block performed intraoperatively for postoperative analgesia.
Bilateral ultrasound-guided erector spinae plane block performed at the T6 vertebral level before surgery using 0.25% bupivacaine. The total dose will not exceed 2 mg/kg. The block is administered in addition to standard general anesthesia and multimodal analgesia.
Patients receive standard perioperative multimodal analgesia without regional anesthesia techniques. Intravenous paracetamol (1 g) and dexketoprofen (50 mg) are administered intraoperatively according to institutional protocol.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Primary Outcome
Ramy czasowe: Postoperative Hours 1, 6, 12, and 24
The primary outcome of this study is the assessment of postoperative pain levels. Pain intensity will be measured using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain) at the 1st, 6th, 12th, and 24th postoperative hours. The effectiveness of the analgesic techniques will be evaluated by comparing VAS scores between the groups.
Postoperative Hours 1, 6, 12, and 24

Współpracownicy i badacze

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Publikacje i pomocne linki

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Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 października 2026

Zakończenie podstawowe (Szacowany)

15 grudnia 2026

Ukończenie studiów (Szacowany)

15 października 2027

Daty rejestracji na studia

Pierwszy przesłany

23 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 września 2026

Pierwszy wysłany (Rzeczywisty)

9 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared because the dataset contains clinical information collected for the primary purpose of this single-center study. Data sharing is not planned due to institutional privacy policies and to protect participant confidentiality. Only aggregated study results will be published.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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